2018 March 16 SPDS

118 119 120

Table 3: Analytical Range & LOQ

Parameter

Minimum Requirement

Analytical range (%, w/w)

1 - 50

Limit of Quantitation (%, w/w)

1

121 122 123 124

Table 4: Method Performance Requirements

Parameter

Minimum Requirement

% Recovery

92-105

% RSD r

≤ 5

% RSD R

≤ 8

125 126 127 128 129 130 131